Fluid dispensing device

ABSTRACT

A fluid dispensing device comprising a body defining a cavity and a dispensing nozzle. A fluid discharging device is housed in the cavity. The fluid discharging device has a hollow casing defining a reservoir for containing a volume of fluid and a plunger slidingly engaged within the hollow casing. The plunger has a tubular portion which is arranged to extend from a first end of the hollow casing for co-operation with the dispensing nozzle. A biasing means is interposed between a second end of the hollow casing and an end wall of the cavity to bias the hollow casing towards the dispensing nozzle. A locking means holds the biasing means in a compressed state. Upon release of the locking means, the force stored in the biasing means is applied to the hollow casing thereby causing fluid to be ejected from the reservoir into the dispensing nozzle.

The present invention relates to a medicament dispenser and inparticular to fluid dispensing device for use as a nasal inhaler.

It is well known to provide a medicament dispenser in which fluid isdispensed via a nozzle or orifice upon the application of a force by auser to an actuation lever or button. Such devices may be arranged todispense a single dose or may alternatively be arranged with a reservoircontaining several doses to be dispensed. An example of such a pumpaction spray is shown and described in U.S. Pat. No. 4,946,069.

It is a problem with such prior art mechanical pumps that the efficacyof supply is dependent upon the manner in which the device is actuatedby the user. If the user actuates the device in a slow or lethargicmanner then the dispensing of the fluid is less efficient than if arapid but constant pressure is brought to bear upon the actuation buttonor lever. In extreme cases the rate of discharge can be so low that fullatomisation is unable to occur and the spray comprises of relativelylarge droplets of fluid.

It will be appreciated that the operation of such a device requires somemanual dexterity and so if the patient has some problems with theirhands the likelihood of an efficient dispensing is low.

It is an object of this invention to provide a fluid dispensing devicethat is easier to use and in particular a device which provides arepeatable dispensing of fluid.

According to a first aspect of the invention there is provided a fluiddispensing device comprising a body defining a cavity and a dispensingnozzle, a fluid discharging device housed in the cavity, the fluiddischarging device having a hollow casing defining a reservoir forcontaining a volume of fluid and a plunger slidingly engaged within thehollow casing, the plunger having a tubular portion which is arranged toextend from a first end of the hollow casing for co-operation with thedispensing nozzle, biasing means interposed between a second end of thehollow casing and an end wall of the cavity to bias the hollow casingtowards the dispensing nozzle and a locking means to hold said biasingmeans in a compressed state wherein upon release of the locking meansthe force stored in the biasing means is applied to the hollow casingthereby causing fluid to be ejected from the reservoir into thedispensing nozzle.

Suitably, the biasing means comprises a spring or other resilientlycompressible mechanical member for storing mechanical energy.

In one aspect, the release of the biasing means from its compressedstate acts such as to cause relative movement between the hollow casingand the plunger so as to eject a unit dose of fluid from the fluidreservoir into the dispensing nozzle.

The plunger may be slideable in a chamber located within the hollowcasing, the chamber being sized to accommodate a single dose of fluid.

The re-setting of the biasing means into its compressed state may causea new dose of fluid to be drawn into the chamber.

The reservoir may contain several doses of fluid.

The locking means may comprise of one or more detents, each of which isengageable with a respective aperture in a side wall of the body whenthe biasing means is in its compressed state.

Preferably, there may be several detents positioned for engagement withrespective apertures in opposite side walls of the body.

The biasing means may be interposed between the end wall of the cavityand a support platform for the hollow casing.

Each detent may be connected to the support platform by a flexible limb.

Alternatively, each detent may be connected to the hollow casing by aflexible limb.

Preferably, each detent may include a portion, which extends outwardlyfrom the side wall with which the detent is engaged to define a triggerthat is operable by a user to release the biasing means from itscompressed state.

The device may further comprise a protective end cap having an innersurface for engagement with the body to protect the dispensing nozzle.

The fitment of the protective end cap to the body may cause theresetting of the biasing means into its compressed state.

The hollow casing may have at least one outwardly extending lug forabutment with a complementary projection formed on the inner surface ofthe end cap to provide a driving connection therebetween.

The body may have at least one longitudinally extending slot throughwhich a respective lug extends.

Preferably, there may be several lugs formed on the hollow casing forengagement with complementary projections formed on the inner surface ofthe end cap, each of the lugs being arranged to extend through alongitudinally extending slot formed in the side wall of the body.

The hollow casing may have at least one outwardly extending detent forengagement with a complementary recess formed in the inner surface ofthe end cap so as to releasable hold the end cap in position on thebody.

Each detent may extend through a respective longitudinally extendingslot in the body for engagement with the respective recess formed in theend cap.

According to a second aspect of the invention there is provided a fluiddispensing apparatus for housing a fluid discharging device, the fluiddispensing apparatus comprising a body defining a cavity, a dispensingnozzle, biasing means housed in the cavity and a locking means toselectively hold said biasing means in a compressed state, wherein, inuse, a fluid discharging device is positioned between the biasing meansand the dispensing nozzle.

The release of the locking means may cause the force stored in thebiasing means to be applied to the fluid discharging device so as tobias the fluid discharging device towards the dispensing nozzle.

Suitably, the fluid discharging device comprises a pre-compression pump,such as a VP3, VP7 or modifications, model manufactured by Valois SA.Typically, such pre-compression pumps are used with a bottle (glass orplastic) capable of holding 8-50 ml of a formulation. Each spray willtypically deliver 50-100 μl of such a formulation and the device istherefore capable of providing at least 100 metered doses.

The fluid dispensing apparatus may further comprise an end cap forengagement with the body wherein the end cap is adapted such that, inuse, engagement of the end cap onto the body will cause compression ofthe biasing means.

The invention will now be described further with reference to theaccompanying drawing in which:

FIG. 1 shows an exploded view of a fluid dispensing device according tothe invention;

FIG. 2 shows a plan view of the fluid dispensing device shown in FIG. 1in a closed or stored condition;

FIG. 3 is a plan view of a body forming part of the device shown in FIG.1 in a discharged state;

FIG. 4 shows the body of FIG. 3 in a ready to discharge state;

FIG. 5 shows the body of FIG. 3 in a discharging state;

FIG. 6 is a side view of the device shown in FIG. 1 showing the devicein a discharged state with a resetting procedure commencing;

FIG. 7 is a view similar to that of FIG. 6 but showing the device afterresetting and with a protective end cap in place; and

FIG. 8 is an enlarged scrap view of the area ‘X’ on FIG. 6.

With reference to the figures there is shown a fluid dispensing device 5comprising a body 6 and a fluid discharging device 8. The device furthercomprises a protective end cap 7 having an inner surface 48 forengagement with the body 6 to protect the dispensing nozzle 11.

The body 6 is made from a plastic material and defines a housing 9 and adispensing nozzle 11.

The housing 9 defines a cavity 10 formed by a side wall 12 and first andsecond end walls 13 and 14. The dispensing nozzle 11 is connected to andextends away from the second end wall 14 and has an external taperingform.

The dispensing nozzle 11 has a longitudinally extending orifice 15defined by an outlet tube 16 extending towards the cavity 10. An annularabutment 17 is formed within the orifice 15 part way along the outlettube 16. The annular abutment 17 defines a small aperture 18 throughwhich fluid can flow in use.

Two guides walls 20 a, 20 b extend into the cavity 10 from the secondend wall 14 of the housing 9 to locate one end of the fluid dischargingdevice 8 in the cavity 10 as will be described in more detailhereinafter.

Near to the first end wall 13 two apertures 21, 22 are formed in theside wall 12 on opposite sides of the housing 9 and towards a mid pointof the housing 9 two longitudinally extending slots 23, 24 are formed inthe side wall 12 in opposite sides of the housing 9.

The longitudinally extending slots 23, 24 are formed in the top andbottom sides of the housing 9 and the apertures 21, 22 are formed in theleft and right sides of the housing 9 which, as shown, is substantiallyoval in cross-section.

It will be appreciated that the shape of the housing need not be oval itcould be cylindrical or any other convenient shape.

The fluid discharging device 8 is in most respects conventional (e.g.taking the form of a conventional nasal pump) and will only be describedbriefly herein.

The fluid discharging device 8 has a hollow casing 30 defining areservoir containing several doses of the fluid to be dispensed and aplunger slidingly engaged within the hollow casing 30.

The plunger is slideable in a chamber located within the hollow casing,the chamber being sized to accommodate a single dose of fluid. Theplunger has a tubular portion 31 which is arranged to extend from afirst end 32 of the hollow casing 30 for co-operation with the outlettube 16 of the dispensing nozzle 11 and a piston (not shown) slidablysupported in a chamber (not shown) located within and is attached to thehollow casing 30.

The release of the spring 40 from its compressed state causes relativemovement between the hollow casing 30 and the plunger so as to eject aunit dose of fluid from the fluid reservoir into the dispensing nozzle11.

The fluid is discharged through a discharge channel defined by thetubular portion 31 of the plunger into the dispensing nozzle 11.

The size of chamber is such that it accommodates a single dose of fluid,the diameter of the chamber and piston combined with the stroke of theplunger being such that a full stroke of the plunger in the chamber willproduce a change in volume equal to a single dose of fluid.

The chamber is connected to the reservoir such that when the piston ismoved by a return spring (not shown) into a start position a new dose offluid is drawn into the cylinder ready for discharge. The re-setting ofthe spring 40 into its compressed state causes a new dose of fluid to bedrawn into the chamber by allowing the piston to move to its startposition.

The hollow casing 30 is slidingly supported within the cavity 10 definedby the housing 9 and is located at its first end 32 by the two guidewalls 20 a, 20 b. The hollow casing 30 is of varying dimension along itslength. In all there are three portions, a small end portion 34 at itsfirst end 32, a large end portion 35 at its second end 33 and a middleportion 36 connecting the two end portions 34, 35.

At the juncture of the small end portion 34 with the middle portion 36there is defined a first step 37 and at the juncture of the middleportion 36 with the large end portion 35 there is defined a second step38.

The second step 38 is arranged to selectively co-operate in use with acomplementary step 39 formed in the side wall 12 of the housing 9 tolimit movement of the hollow casing 30 towards the dispensing nozzle 11.

A spring 40 is interposed between the second end 33 of the hollow casing30 and the first end wall 13 of the housing 9 to bias the hollow casing30 towards the dispensing nozzle 11. The spring 40 is interposed betweenthe end wall 13 of the cavity 10 and a support platform 41 for thehollow casing 30.

As shown the spring 40 is in the form of a helical compression springbut it will be appreciated that other types of spring could be used suchas rubber springs or gas springs.

The support platform 41 for the hollow casing 30 is interposed betweenthe spring 40 and the second end 33 of the hollow casing 30.

The support platform 41 provides two functions it distributes the loadfrom the spring into the second end 33 of the hollow casing and supportsother components used as a locking means to selectively hold the springin a compressed, cocked or set state. This enables a standard fluiddischarging device to be used without modification.

Two detents 44 a, 44 b forming part of the locking means are alsoprovided, each detent is connected to the support platform 41 by aflexible limb 43 a, 43 b.

The support platform 41 has a base portion 42 from which extend the twoflexible limbs 43 a, 43 b supporting the two detents 44 a, 44 b formingpart of the locking means. A location pip 46 is formed on the baseportion 42 to centralise the spring 40 and a corresponding location pip47 is formed on the first end wall 13 of the housing 9.

The locking means comprises of one or more detents, each of which isengageable with a respective aperture in a side wall of the body whenthe spring is in its compressed state. In the exemplary embodiment thelocking means comprises of the two detents 44 a, 44 b and the twoapertures 21, 22 in the housing 9.

Each of the detents 44 a, 44 b is engageable with one of the apertures21, 22 to form a selectively releasable latch capable of holding thespring 40 in a compressed state. The two limbs 43 a, 43 b areelastically deformed by their containment within the cavity 10 and theforce produced by this containment is used to bias the detents 44 a, 44b into the apertures 21, 22.

Ideally, there are several detents positioned for engagement withrespective apertures in opposite side walls of the body.

The two detents 44 a, 44 b are sized such that an outer portion 45 ofeach detent 44 a, 44 b projects outwardly from the side wall 12 of thehousing 9 through which the detent 44 a, 44 b extends. Each detent 44 a,44 b includes a portion 45 which extends outwardly from the side wall 12with which the detent 44 a, 44 b is engaged to define a trigger that isoperable by a user to release the spring 40 from its compressed state.

The outer portions 45 are therefore used by a user as a trigger torelease the detents 44 a, 44 b from the apertures 21, 22 and hencerelease the locking means.

The end cap 7 is a tubular component which is closed at one end and hasa thin flexible side wall 57. An inner surface 48 of the side wall 57defines a cavity into which the body 6 is engaged to protect thedispensing nozzle 11. It is envisaged that the end cap may be attachedto the body by a flexible strap or tether which could be moulded as partof the end cap and body.

The fitment of the protective end cap 7 to the body 6 causes theresetting of the spring 40 into its compressed state as will bedescribed in more detail hereinafter. The hollow casing 30 has at leastone outwardly extending detent for engagement with a complementaryrecess formed in the inner surface 48 of the end cap 7 so as toreleasable hold the end cap 7 in position on the body 6. Each detentextends through a respective longitudinally extending slot in the bodyfor engagement with the respective recess formed in the end cap.

The inner surface 48 of the exemplary embodiment has a recess 49 formedtherein for co-operation with two detents 51 formed on the middleportion 36 of the hollow casing 30. The detents 51 and the groove 49co-operate to provide a snap connection between the end cap 7 and thebody 6. The snap connection is used to hold the end cap 7 on the body 6when the fluid dispensing device 5 is in a stored or non-use condition.

The hollow casing 30 has at least one outwardly extending lug 52 forabutment with a complementary projection 50 formed on the inner surface48 of the end cap 7 to provide a driving connection therebetween.

There are several lugs 52 formed on the hollow casing 30 for engagementwith complementary projections formed on the inner surface 48 of the endcap 7, each of the lugs 52 being arranged to extend through alongitudinally extending slot formed in the side wall of the body.

The inner surface 48 of the end cap 7 of the exemplary embodiment hastwo projections 50 formed thereon for co-operation with two lugs 52formed in the middle portion 36 of the hollow casing 30.

The two lugs 52 are positioned close to but are spaced away from the twodetents 51. The two lugs 52 are further from the first end 32 of thehollow casing 30 than the two detents 51.

The two detents 51 have inclined surfaces 53 facing towards the firstend 32 of the hollow casing 30 so that the projections 50 can easilyride up over them whereas the two lugs 52 have leading surfaces 54facing towards the first end 32 of the hollow casing 30 that aresubstantially normal to the side wall 12 of the hollow casing 30.

The leading surfaces 54 of the lugs 52 form in combination withcorresponding leading faces 56 on the projections 50 a drivingconnection between the end cap 7 and the hollow casing 30 which is usedto re-set the spring mechanism.

The trailing faces 55 of the projections 50 are inclined so that theprojections 50 can ride up over the detents 51 when the end cap 7 ispulled off of the body 6 to ready the fluid dispensing device 5 for use.

The detents 51 and the lugs 52 extend through the longitudinallyextending slots 21 formed in the side wall 12 of the housing 9 forco-operation with the complementary recesses 49 and projections 50 inthe end cap 7. The side wall 57 of the end cap 7 is sufficientlyflexible to allow the end cap 7 to expand as it passes over the housing9 and the corresponding tension placed into the side wall 57 of the endcap 7 is used to bias the detents 51 into the recesses 49.

Therefore it can seen that the exemplary embodiment discloses a fluiddispensing device comprising a body defining a cavity and a dispensingnozzle, a fluid discharging device housed in the cavity, the fluiddischarging device having a hollow casing defining a reservoircontaining a volume of fluid and a plunger slidingly engaged within thehollow casing, the plunger having a tubular portion which is arranged toextend from a first end of the hollow casing for co-operation with thedispensing nozzle, a spring interposed between a second end of thehollow casing and an end wall of the cavity to bias the hollow casingtowards the dispensing nozzle and a locking means to hold the spring ina compressed state wherein upon release of the locking means the forcestored in the spring is applied to the hollow casing thereby causingfluid to be ejected from the reservoir into the dispensing nozzle.Operation of the exemplary fluid dispensing device is as follows.

FIG.3 shows the fluid dispensing device 5 in a used or exhausted state.In this state the spring 40 is in a relaxed condition and little or noload is applied to the hollow casing 30 via the support platform 41.

In order to re-cock or reset the mechanism the hollow casing 30 must bemoved towards the first end wall 13 so as to compress the spring 40.This re-setting or re-cocking is done by a replacing the end cap 7 ontothe body 6.

As the end cap 7 is engaged with the body 6 the projections 50 on theinner surface 48 of the end cap 7 engage with the lugs 52 on the hollowcasing 30. Further movement off the end cap 7 into engagement with thebody 6 after this initial contact will result in the hollow casing 30being moved towards the first end wall 13 of the housing 9 therebycompressing the spring 40.

This movement is continued by the user until the detents 44 a, 44 bengage with the apertures 21, 22 in the housing 9. In this position themechanism is said to be in a set or cocked state and is ready for use.

During the action of resetting the mechanism the plunger is able toreturn to a starting position and this action causes a new dose of fluidto be drawn into the cylinder.

FIG. 4 shows the fluid dispensing device 5 in the re-set or cockedstate.

To use the device the user has to firstly remove the end cap 7 from thebody and place the free end of the dispensing nozzle into the orificeinto which fluid is to be sprayed or dispensed.

To dispense the fluid the user then has to press the two triggers 45inwardly to release the detents 44 a, 44 b from the apertures 21, 22.The disengagement of the detents 44 a, 44 b from the apertures 21, 22allows the force stored in the spring 40 to be applied to the hollowcasing 30. The application of this spring force causes the hollow casing30 to move rapidly towards the second end wall 14 of the housing 9.

Initially, no fluid will be dispensed because the end of the tubularportion 31 of the plunger is not in contact with any other structure.This is because the movement of the hollow casing 30 between theexhausted and re-set positions is greater than the stroke of the pistonin the cylinder.

However when the end of the hollow portion 31 of the plunger contactsthe annular abutment 17 in the outlet tube 16 any further movement ofthe hollow casing 30 towards the second end wall 14 will result in acorresponding relative movement between the hollow casing 30 and theplunger.

This relative movement between the hollow casing 30 and the plunger willresult in a corresponding movement of the piston in the cylinder andconsequently any fluid contained within the cylinder will be ejected outof the cylinder into the hollow portion 31 of the plunger and from therevia the aperture 19 in the annular abutment 18 into the orifice 15 inthe dispensing nozzle 11.

Because of the free travel in the mechanism due to the difference in thestroke of the piston and the travel the hollow casing 30, a short travelbut fast acting motion is applied to the piston. This action results ina rapid ejection of the fluid from the chamber with the result that agood atomisation of the fluid is produced as it exits the dispensingnozzle 11.

In addition, because the dispensing of the fluid is solely dependentupon the action of the spring upon the hollow casing it is far morerepeatable and reliable than a system reliant upon the force and speedof application of a force by a user.

By using the end cap to re-set or re-cock the spring the user knows thatas soon as the end cap is removed the device is ready to discharge fluidand no other action is required.

In addition, because it is usual for a user to replace the end cap ontothe body after each use, the user does not have to remember to re-setthe device, the action of replacing the end cap automatically completesthis procedure.

Although the invention has been described in relation to a device havinga fluid discharging device sealed within the housing it will beappreciated that the housing could have a removable end or be openablein some other manner to allow the fluid discharging device to bereplaced.

It will be further appreciated that the use of a support platform is notessential and that if required the hollow casing could be designed suchthat the biasing means could act directly thereupon. In addition, thehollow casing could be made such that the detents used to hold thebiasing means in a compressed state are connected directly to the hollowcasing via flexible limbs formed as part of the hollow casing.

A fluid dispensing apparatus for housing a fluid discharging deviceforming a second aspect of the invention is also disclosed. The fluiddispensing apparatus is in all respects the same as the fluid dispensingdevice previously described with the exception that it does not containa fluid discharging device.

The fluid discharging apparatus therefore comprises of a body defining acavity, a dispensing nozzle, biasing means housed in the cavity and alocking means to selectively hold the biasing means in a compressedstate, wherein, in use, a fluid discharging device is positioned betweenthe biasing means and the dispensing nozzle.

In use the release of the locking means will cause the force stored inthe biasing means to be applied to a fluid discharging device so as tobias the fluid discharging device towards the dispensing nozzle.

The fluid dispensing apparatus further comprises an end cap forengagement with the body, the end cap being adapted such that, in use,engagement of the end cap onto the body will cause compression of thebiasing means.

It is envisaged that the fluid discharging apparatus could be sold as anitem into which a fluid discharging device is fitted by a user orpharmacist.

Administration of medicament may be indicated for the treatment of mild,moderate or severe acute or chronic symptoms or for prophylactictreatment. It will be appreciated that the precise dose administeredwill depend on the age and condition of the patient, the particularmedicament used and the frequency of administration and will ultimatelybe at the discretion of the attendant physician. When combinations ofmedicaments are employed the dose of each component of the combinationwill in general be that employed for each component when used alone.

Appropriate medicaments may thus be selected from, for example,analgesics, e.g., codeine, dihydromorphine, ergotamine, fentanyl ormorphine; anginal preparations, e.g., diltiazem; antiallergics, e.g.,cromoglycate (eg as the sodium salt), ketotifen or nedocromil (eg as thesodium salt); antiinfectives e.g., cephalosporins, penicillins,streptomycin, sulphonamides, tetracyclines and pentamidine;antihistamines, e.g., methapyrilene; anti-inflammatories, e.g.,beclomethasone (eg as the dipropionate ester), fluticasone (eg as thepropionate ester), flunisolide, budesonide, rofleponide, mometasone (egas the furoate ester), ciclesonide, triamcinolone (eg as the acetonide),6α,9α-difluoro-11β-hydroxy-16α-methyl-3-oxo-17α-propionyloxy-androsta-1,4-diene-17β-carbothioicacid S-(2-oxo-tetrahydro-furan-3-yl)ester or6α,9α-Difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioic acid S-fluoromethyl ester; antitussives,e.g., noscapine; bronchodilators, e.g., albuterol (eg as free base orsulphate), salmeterol (eg as xinafoate), ephedrine, adrenaline,fenoterol (eg as hydrobromide), formoterol (eg as fumarate),isoprenaline, metaproterenol, phenylephrine, phenylpropanolamine,pirbuterol (eg as acetate), reproterol (eg as hydrochloride), rimiterol,terbutaline (eg as sulphate), isoetharine, tulobuterol or4-hydroxy-7-[2-[[2-[[3-(2-phenylethoxy)propyl]sulfonyl]ethyl]amino]ethyl-2(3H)-benzothiazolone;PDE4 inhibitors eg cilomilast or roflumilast; leukotriene antagonists egmontelukast, praniukast and zafirlukast; [adenosine 2a agonists, eg2R,3R,4S,5R)-2-[6-Amino-2-(1S-hydroxymethyl-2-phenyl-ethylamino)-purin-9-yl]-5-(2-ethyl-2H-tetrazol-5-yl)-tetrahydro-furan-3,4-diol(e.g. as maleate)]*; [α4 integrin inhibitors eg(2S)-3-[4-({[4-(aminocarbonyl)-1-piperidinyl]carbonyl}oxy)phenyl]-2-[((2S)-4-methyl-2-{[2-(2-methylphenoxy)acetyl]amino}pentanoyl)amino]propanoicacid (e.g as free acid or potassium salt)]*, diuretics, e.g., amiloride;anticholinergics, e.g., ipratropium (eg as bromide), tiotropium,atropine or oxitropium; hormones, e.g., cortisone, hydrocortisone orprednisolone; xanthines, e.g., aminophylline, choline theophyllinate,lysine theophyllinate or theophylline; therapeutic proteins andpeptides, e.g., insulin or glucagons. It will be clear to a personskilled in the art that, where appropriate, the medicaments may be usedin the form of salts, (e.g., as alkali metal or amine salts or as acidaddition salts) or as esters (e.g., lower alkyl esters) or as solvates(e.g., hydrates) to optimise the activity and/or stability of themedicament and/or to minimise the solubility of the medicament in thepropellant.

Preferably, the medicament is an anti-inflammatory compound for thetreatment of inflammatory disorders or diseases such as asthma andrhinitis.

In one aspect, the medicament is a glucocorticoid compound, which hasanti-inflammatory properties. One suitable glucocorticoid compound hasthe chemical name:6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester (fluticasone propionate). Another suitableglucocorticoid compound has the chemical name:6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β,-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester. A further suitable glucocorticoid compoundhas the chemical name:6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.

Other suitable anti-inflammatory compounds include NSAIDs e.g. PDE4inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase andelastase inhibitors, beta-2 integrin antagonists and adenosine 2aagonists.

The medicament is formulated as any suitable fluid formulation,particularly a solution (e.g. aqueous) formulation or a suspensionformulation, optionally containing other pharmaceutically acceptableadditive components.

Suitable formulations (e.g. solution or suspension) may be stabilised(e.g. using hydrochloric acid or sodium hydroxide) by appropriateselection of pH. Typically, the pH will be adjusted to between 4.5 and7.5, preferably between 5.0 and 7.0, especially around 6 to 6.5.

Suitable formulations (e.g. solution or suspension) may comprise one ormore excipients. By the term “excipient”, herein, is meant substantiallyinert materials that are nontoxic and do not interact with othercomponents of a composition in a deleterious manner including, but notlimited to, pharmaceutical grades of carbohydrates, organic andinorganic salts, polymers, amino acids, phospholipids, wetting agents,emulsifiers, surfactants, poloxamers, pluronics, and ion exchangeresins, and combinations thereof.

Suitable carbohydrates include monosaccharides include fructose;disaccharides, such as, but not limited to lactose, and combinations andderivatives thereof; polysaccharides, such as, but not limited to,cellulose and combinations and derivatives thereof; oligosaccharides,such as, but not limited to, dextrins, and combinations and derivativesthereof; polyols, such as but not limited to sorbitol, and combinationsand derivatives thereof.

Suitable organic and inorganic salts include sodium or calciumphosphates, magnesium stearate, and combinations and derivativesthereof.

Suitable polymers include natural biodegradable protein polymers,including, but not limited to, gelatin and combinations and derivativesthereof; natural biodegradable polysaccharide polymers, including, butnot limited to, chitin and starch, crosslinked starch and combinationsand derivatives thereof; semisynthetic biodegradable polymers,including, but not limited to, derivatives of chitosan; and syntheticbiodegradable polymers, including, but not limited to, polyethyleneglycols (PEG), polylactic acid (PLA), synthetic polymers including butnot limited to polyvinyl alcohol and combinations and derivativesthereof;

Suitable amino acids include non-polar amino acids, such as leucine andcombinations and derivatives thereof. Suitable phospholipids includelecithins and combinations and derivatives thereof.

Suitable wetting agents, surfactants and/or emulsifiers include gumacacia, cholesterol, fatty acids including combinations and derivativesthereof. Suitable poloxamers and/or Pluronics include poloxamer 188,Pluronic® F-108, and combinations and derivations thereof. Suitable ionexchange resins include amberlite IR120 and combinations and derivativesthereof;

Suitable solution formulations may comprise a solubilising agent such asa surfactant. Suitable surfactants includeα-[4-(1,1,3,3-tetramethylbutyl)phenyl]-ω-hydroxypoly(oxy-1,2-ethanediyl)polymersincluding those of the Triton series e.g. Triton X-100, Triton X-114 andTriton X-305 in which the X number is broadly indicative of the averagenumber of ethoxy repeating units in the polymer (typically around 7-70,particularly around 7-30 especially around 7-10) and4-(1,1,3,3-tetramethylbutyl)phenol polymers with formaldehyde andoxirane such as those having a relative molecular weight of 3500-5000especially 4000-4700, particularly Tyloxapol. The surfactant istypically employed in a concentration of around 0.5-10%, preferablyaround 2-5% w/w based on weight of formulation.

Suitable solution formulations may also comprise hydroxyl containingorganic co-solvating agents include glycols such as polyethylene glycols(eg PEG 200) and propylene glycol; sugars such as dextrose; and ethanol.Dextrose and polyethylene glycol (eg PEG 200) are preferred,particularly dextrose. Propylene glycol is preferably used in an amountof no more than 20%, especially no more than 10% and is most preferablyavoided altogether. Ethanol is preferably avoided. The hydroxylcontaining organic co-solvating agents are typically employed at aconcentration of 0.1-20% e.g. 0.5-10%, e.g. around 1-5% w/w based onweight of formulation.

Suitable solution formulations may also comprise solublising agents suchas polysorbate, glycerine, benzyl alcohol, polyoxyethylene castor oilsderivatives, polyethylene glycol and polyoxyethylene alkyl ethers (e.g.Cremophors, Brij).

Suitable solution formulations may also comprise one or more of thefollowing components: viscosity enhancing agents; preservatives; andisotonicity adjusting agents.

Suitable viscosity enhancing agents include carboxymethylcellulose,veegum, tragacanth, bentonite, hydroxypropylmethylcellulose,hydroxypropylcellulose, hydroxyethylcellulose, poloxamers (eg. poloxamer407), polyethylene glycols, alginates xanthym gums, carageenans andcarbopols.

Suitable preservatives include quaternary ammonium compounds (e.g.benzalkonium chloride, benzethonium chloride, cetrimide andcetylpyridinium chloride), mercurial agents (e.g. phenylmercuricnitrate, phenylmercuric acetate and thimerosal), alcoholic agents (e.g.chlorobutanol, phenylethyl alcohol and benzyl alcohol), antibacterialesters (e.g. esters of para-hydroxybenzoic acid), chelating agents suchas disodium edetate (EDTA) and other anti-microbial agents such aschlorhexidine, chlorocresol, sorbic acid and its salts and polymyxin.

Suitable isotonicity adjusting agents act such as to achieve isotonicitywith body fluids (e.g. fluids of the nasal cavity), resulting in reducedlevels of irritancy associated with many nasal formulations. Examples ofsuitable isotonicity adjusting agents are sodium chloride, dextrose andcalcium chloride.

Suitable suspension formulations comprise an aqueous suspension ofparticulate medicament and optionally suspending agents, preservatives,wetting agents or isotonicity adjusting agents.

The particulate medicament suitably has a mass mean diameter (MMD) ofless than 20 μm, preferably between 0.5-10 μm, especially between 1-5μm. If particle size reduction is necessary, this may be achieved bytechniques such as micronisation and/or microfluidisation.

Suitable suspending agents include carboxymethylcellulose, veegum,tragacanth, bentonite, methylcellulose and polyethylene glycols.

Suitable wetting agents function to wet the particles of medicament tofacilitate dispersion thereof in the aqueous phase of the composition.Examples of wetting agents that can be used are fatty alcohols, estersand ethers. Preferably, the wetting agent is a hydrophilic, non-ionicsurfactant, most preferably polyoxyethylene (20) sorbitan monooleate(supplied as the branded product Polysorbate 80).

Suitable preservatives and isotonicity adjusting agents are as describedabove in relation to solution formulations.

The dispensing device herein is suitable for dispensing fluid medicamentformulations for the treatment of inflammatory and/or allergicconditions of the nasal passages such as rhinitis e.g. seasonal andperennial rhinitis as well as other local inflammatory conditions suchas asthma, COPD and dermatitis.

A suitable dosing regime would be for the patient to inhale slowlythrough the nose subsequent to the nasal cavity being cleared. Duringinhalation the formulation would be applied to one nostril while theother is manually compressed. This procedure would then be repeated forthe other nostril. Typically, one or two inhalations per nostril wouldbe administered by the above procedure up to three times each day,ideally once daily. Each dose, for example, may deliver 5 μg, 50 μg, 100μg, 200 μg or 250 μg of active medicament. The precise dosage is eitherknown or readily ascertainable by those skilled in the art.

It will be understood that the present disclosure is for the purpose ofillustration only and the invention extends to modifications, variationsand improvements thereto.

The application of which this description and claims form part may beused as a basis for priority in respect of any subsequent application.The claims of such subsequent application may be directed to any featureor combination of features described therein. They may take the form ofproduct, method or use claims and may include, by way of example andwithout limitation, one or more of the following. claims:

1. A fluid dispensing device comprising a body defining a cavity and adispensing nozzle, a fluid discharging device housed in the cavity, thefluid discharging device having a hollow casing defining a reservoir forcontaining a volume of fluid and a plunger slidingly engaged within thehollow casing, the plunger having a tubular portion which is arranged toextend from a first end of the hollow casing for co-operation with thedispensing nozzle, biasing means interposed between a second end of thehollow casing and an end wall of the cavity to bias the hollow casingtowards the dispensing nozzle and a locking means to hold said biasingmeans in a compressed state wherein upon release of the locking meansthe force stored in the biasing means is applied to the hollow casingthereby causing fluid to be ejected from the reservoir into thedispensing nozzle.
 2. A device as claimed in claim 1 in which therelease of the biasing means from its compressed state causes relativemovement between the hollow casing and the plunger so as to eject a unitdose of fluid from the fluid reservoir into the dispensing nozzle.
 3. Adevice as claimed in claim 1 in which the plunger is slideable in achamber located within the hollow casing, the chamber being sized toaccommodate a single dose of fluid.
 4. A device as claimed in claim 3 inwhich the re-setting of the biasing means into its compressed statecauses a new dose of fluid to be drawn into the chamber.
 5. A device asclaimed in claim 1 in which the reservoir contains several doses offluid.
 6. A device as claimed in claim 1 in which the locking meanscomprises of one or more detents, each of which is engageable with arespective aperture in a side wall of the body when the biasing means isin its compressed state.
 7. A device as claimed in claim 6 in whichthere are several detents positioned for engagement with respectiveapertures in opposite side walls of the body.
 8. A device as claimed inclaim 1 in which the biasing means is interposed between the end wall ofthe cavity and a support platform for the hollow casing.
 9. A device asclaimed in claim 8, in which the locking means comprises of one or moredetents, each of which is engageable with a respective aperture in aside wall of the body when the biasing means is in its compressed state,and in which each detent is connected to the support platform by aflexible limb.
 10. A device as claimed in claim 6 in which each detentis connected to the hollow casing by a flexible limb.
 11. A device asclaimed in claim 6 in which each detent includes a portion which extendsoutwardly from the side wall with which the detent is engaged to definea trigger that is operable by a user to release the biasing means fromits compressed state.
 12. A device of claim 1 further comprising aprotective end cap having an inner surface for engagement with the bodyto protect the dispensing nozzle.
 13. A device as claimed in claim 12,wherein the fitment of the protective end cap to the body causes theresetting of the biasing means into its compressed state.
 14. A deviceas claimed in claim 12 in which the hollow casing has at least oneoutwardly extending lug for abutment with a complementary projectionformed on the inner surface of the end cap to provide a drivingconnection therebetween.
 15. A device as claimed in claim 14 in whichthe body has at least one longitudinally extending slot through which arespective lug extends.
 16. A device as claimed in claim 15 in whichthere are several lugs formed on the hollow casing for engagement withcomplementary projections formed on the inner surface of the end cap,each of the lugs being arranged to extend through a longitudinallyextending slot formed in the side wall of the body.
 17. A device asclaimed in claim 12 in which the hollow casing has at least oneoutwardly extending detent for engagement with a complementary recessformed in the inner surface of the end cap so as to releasable hold theend cap in position on the body.
 18. A device as claimed in claim 17 inwhich each detent extends through a respective longitudinally extendingslot in the body for engagement with the respective recess formed in theend cap.
 19. A fluid dispensing apparatus for housing a fluiddischarging device the fluid dispensing apparatus comprising a bodydefining a cavity, a dispensing nozzle, biasing means housed in thecavity and a locking means to selectively hold said biasing means in acompressed state, wherein, in use, a fluid discharging device ispositioned between the biasing means and the dispensing nozzle.
 20. Afluid dispensing apparatus as claimed in claim 19 wherein, in use, therelease of the locking means will cause the force stored in the biasingmeans to be applied to the fluid discharging device so as to bias thefluid discharging device towards the dispensing nozzle.
 21. A fluiddispensing apparatus as claimed in claim 19 in which the fluiddispensing apparatus further comprises an end cap for engagement withthe body wherein the end cap is adapted such that, in use, engagement ofthe end cap onto the body will cause compression of the biasing means.22. A fluid dispensing device as claimed in claim 1 wherein saidreservoir contains a volume of fluid medicament formulation.
 23. Adevice as claimed in claim 22, wherein said fluid medicament formulationis in the form of a solution formulation.
 24. A device as claimed inclaim 22, wherein said fluid medicament formulation is in the form of asuspension formulation.
 25. A device as claimed in, wherein the fluidmedicament formulation comprises an anti-inflammatory medicamentcompound.
 26. A device as claimed in claim 25, wherein said medicamentcompound is a glucocorticoid compound.
 27. A device as claimed in claim26, wherein said glucocorticoid compound is selected from the groupconsisting of6α,9α-Difluoro-17α-(1-oxopropoxy)-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester;6α,9α-difluoro-17α-[(2-furanylcarbonyl)oxy]-11β-hydroxy-16α-methyl-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester; and6α,9α-Difluoro-11β-hydroxy-16α-methyl-17α-[(4-methyl-1,3-thiazole-5-carbonyl)oxy]-3-oxo-androsta-1,4-diene-17β-carbothioicacid S-fluoromethyl ester.
 28. A device as claimed in claim 25, whereinsaid medicament compound is selected from the group consisting of PDE4inhibitors, leukotriene antagonists, iNOS inhibitors, tryptase andelastase inhibitors, beta-2 integrin antagonists and adenosine 2aagonists.